PeRiOperative Medicine Platform Trial

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMonash University

About this trial

Our specific aims are to investigate whether conservative (≤30%), intermediate (50%), or liberal (80%) inspired oxygen during and immediately after surgery: Aim 1: Reduces surgical site infections (SSIs or "wound infections") and other healthcare-associated infections (pneumonia and sepsis). Aim 2: Reduces a pooled composite of serious postoperative complications, leading to a faster and more complete recovery after surgery, and thus increases "days alive and at home up to 30 days after surgery" (DAH30). Primary hypothesis: Liberal (80%) oxygen concentration delivered with anesthesia in patients undergoing major surgery reduces the incidence of SSIs after surgery compared to conservative (≤30%) or intermediate (50%) oxygen concentration. Secondary hypothesis: Hyperoxia (50-80%) delivered with anesthesia in patients undergoing major surgery increases the incidence of pulmonary and other complications after surgery compared to conservative (≤30%) oxygen concentration, resulting in fewer Days At Home (DAH). PROMPT enrolls patients undergoing elective or semi-elective surgery.

Eligibility criteria

Qualifiers

Adult patient (≥18 years of age at time of admission)

Scheduled to undergo a surgical procedure involving a skin incision, with an expected duration of at least 2 hours, and a planned overnight hospital stay of at least 1 night (including, but not limited to, cardiac surgery, orthopedic surgery, obstetric, or gynecological surgery).

Disqualifiers

ASA physical status 5 (moribund, not expected to survive with or without an operation)

Inability to provide informed consent

Previous participation in PROMPT within the prior 30 days.

ASA physical status 1 or 2

Trial design

Treatments tested in this trial

  • Liberal inspired oxygen
  • Conservative inspired oxygen
  • Intermediate inspired oxygen

Treatment groups

7,800 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Monash University

Lead sponsor

The Alfred

Collaborator

Wellington Hospital

Collaborator